FDA Approves New CoreValve TAVR Device

Reduced size allows placement in smaller vessels, company says.

(Reuters) -- Medtronic said the U.S. Food and Drug Administration approved a new version of its catheter-based heart valve replacement device, making it the first re-capturable and repositionable device available in the U.S.

The CoreValve Evolut-R system is approved for transcatheter aortic valve replacement (TAVR) in severe aortic stenosis patients who are at high or extreme risk for surgery.

The device has a smaller delivery system than the previous version, which means it can be used to treat patients with smaller vessels, Medtronic said in a statement.

Another feature of the device is that a doctor can re-capture or redeploy the device, if required, during a procedure, the company said.

"This feature can avoid the costly error of deploying a second device and reduces complications from mal-positioned devices," Evercore ISI analysts wrote in a note.

"In a short time, the TAVR procedure has become an established treatment option for high risk patients with severe aortic stenosis who are unable undergo surgery, and physicians are looking to technology advancements to help deliver even better patient outcomes," Dr. Mathew Williams, co-primary investigator for the study, as well as chief of Adult Cardiac Surgery and director of Interventional Cardiology and Structural Heart at the NYU Langone Medical Center in New York City, said in the Medtronic statement.

"Clinical data have shown the best patient outcomes are achieved when the valve is properly positioned. The advancement of re-capturability with Evolut R gives physicians more confidence during the procedure and provides advantages that are nonexistent in other TAVR systems," he added.

Evolut-R, launched in the U.S. on Tuesday, was approved by European health regulators earlier this year.

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